CanaryBio Initiates Phase 2 Clinical Trial for Treatment-Resistant Ovarian Cancer Patients

[Asia Economy Reporter Jang Hyowon] Canaria Bio announced on the 24th that it has started recruiting patients for a clinical trial of a combination therapy of Oregovomab and PLD (PEGylated Liposomal Doxorubicin) for the treatment of recurrent ovarian cancer, in collaboration with Professor Lee Jung-yoon’s Obstetrics and Gynecology team at Yonsei University Severance Hospital.

In this clinical trial, Canaria Bio will support the trial by providing necessary investigational drugs, while Professor Lee Jung-yoon’s team will conduct the investigator-initiated clinical trial according to the protocol, including patient recruitment, drug administration, and data collection.

In this regard, Professor Lee Jung-yoon’s team has initiated a Phase 2 clinical trial evaluating Oregovomab and PLD in patients with PARP (poly ADP-ribose polymerase, a cancer cell DNA repair enzyme) inhibitor-resistant ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who are not suitable for platinum-based chemotherapy retreatment.

This clinical trial by Professor Lee’s team is being conducted on the patient group with recurrent ovarian cancer, which is currently the most difficult to treat and has the highest unmet medical needs. Specifically, patient enrollment has begun targeting those who have failed PARP inhibitor therapy, which is used as first-line maintenance treatment for ovarian cancer, and those who show resistance to platinum-based chemotherapy, the primary treatment.

Professor Lee Jung-yoon stated, “This clinical trial is expected to show excellent therapeutic effects as it is a combination therapy of PLD, not a platinum-based chemotherapy, and a new immuno-oncology drug, Oregovomab.” The study has received approval from the Korean Society of Gynecologic Oncology and will involve major hospitals in Korea. It has also been approved by the Asian Society of Gynecologic Oncology and will be conducted not only in Korea but also in Singapore.

Ovarian cancer is the most fatal gynecologic cancer, with a globally increasing incidence. In Korea, the incidence of ovarian cancer has been rising over the past five years, and notably, the ovarian cancer mortality rate in 2019 was 42.7%, which is very high compared to other female cancers. Although ovarian cancer responds well to initial chemotherapy, most patients experience recurrence, and after several rounds of chemotherapy, the response rate to any anticancer drug drops to 5-10%, which is very low.

The first-line treatment for ovarian cancer generally involves maximal cytoreductive surgery followed by platinum-based chemotherapy. Carboplatin, a representative chemotherapeutic agent, is used for patients with advanced and recurrent ovarian cancer, and Avastin is used for ovarian cancer patients with residual tumors after optimal debulking surgery. Additionally, PARP inhibitors such as Lynparza and Zejula are used for patients with DNA damage repair gene (BRCA) mutations and homologous recombination deficiency (HRD) positivity.

However, the expanded clinical use of existing anticancer drugs such as platinum-based agents, Avastin, and PARP inhibitors induces acquired resistance. Ovarian cancer responds well to initial chemotherapy, but most patients experience recurrence, and after several rounds of chemotherapy, the response rate to any anticancer drug drops to 5-10%, which is very low. From this perspective, the clinical trial of the combination therapy of Oregovomab and PLD is expected to meet the clinical strategy demands for overcoming resistance to existing anticancer drugs.

Oregovomab is a monoclonal antibody being developed by Canaria Bio as a novel anticancer drug for ovarian cancer. It has an excellent mechanism of action by binding to the ovarian cancer marker CA-125 and activating the patient’s immune cells to kill cancer cells. Results from a previous Phase 2 clinical trial (QPT-ORE-002: NCT01616303) confirmed that adding Oregovomab to standard chemotherapy in patients with advanced ovarian cancer showed clinically significant improvement without additional toxicity.

Furthermore, the research team is currently modifying the clinical trial protocol to add a cohort combining Oregovomab with weekly paclitaxel therapy. This cohort is planned to allow enrollment regardless of previous chemotherapy lines, which is significant for patients who have difficulty finding treatment options.

A representative from Canaria Bio said, “PLD and paclitaxel are widely used in ovarian cancer treatment, and with the known potential to enhance immunotherapy efficacy, we expect positive results from Professor Lee’s investigator-initiated clinical trial.” They added, “The combination therapy with Oregovomab is expected to minimize the severe side effects of existing ovarian cancer treatments and improve therapeutic effects even in patients resistant to current therapies, thereby offering hope to patients who have been difficult to treat.”

Currently, Canaria Bio is conducting investigator-initiated clinical trials on combination therapies of Oregovomab with other targeted anticancer agents such as Zejula (a PARP inhibitor) or Avastin in patients with recurrent ovarian cancer. This clinical trial with Professor Lee’s team targets patients showing resistance to existing anticancer treatments. Canaria Bio aims to develop treatments applicable to all ovarian cancer indications, including advanced, recurrent, and chemotherapy-resistant cases, and to expand its market share in ovarian cancer therapeutics through positive outcomes from these clinical trials.

This content was produced with the assistance of AI translation services.